FDA Medical Device Recalls (openFDA)
Sekisui Diagnostics P.E.I. Inc.: Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma
- Recall number
- Z-1078-2017
- Recalling firm
- Sekisui Diagnostics P.E.I. Inc.
- Product
- Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma
- Status
- Terminated
- Initiated
- 2016-11-29
- Posted
- 2017-01-23
- Terminated
- 2017-07-06
- Reason
- Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear range.
- Root cause
- Material/Component Contamination
- Action
- Sekisui Diagnostics sent an Important Product Correction Notification letter dated November 29, 2016, to all affected customers. Customers were asked to take the following actions: Customer Instructions: Please stop using and discard any of the Ammonia L3K reagent lots listed above in your inventory; Contact your distributor to discuss replacement product. Distributor Instructions: Please send the "IMPORTANT PRODUCT CORRECTION Customer Notification" provided to all customers that received Sekisui Diagnostics Ammonia LJK from the listed lot numbers; Complete, sign and return the attached CONFIRMATION OF NOTIFICATION form by FAX to the number provided. This will: Indicate receipt of this Field Correction, and confirmation of notification of customers that received impacted customers; Act as confirmation of destruction of affected product in inventory; Allow for issuance of replacement product. Customers with questions were instructed to contact Technical Services at 1-800-565-0265 or email PEIDiagnosticTechnical@sekisui-dx.com.
- Quantity
- 774 Liters bulk and 565 kits
- Distribution
- Worldwide Distribution - US including DE, KS, FL, TX, CA, MI, TN, MA, ID, NJ, RI, IL and Internationally to Austria, Mexico, Canada, India, South Korea, China, Spain, South Korea, and Sri Lanka
- Lot, serial or model codes
- Catalog Number: 293-80-91; Lot Numbers: 48737, 48962, 49087, 49220, 49258 and Catalog Numbers: 293-10; Lot Numbers: 48967, 49330, 49331, 49515
- 510(k) numbers
- ["K033921"]
- PMA numbers
- not on file
- Product code
- JIF
- Firm FEI
- 3002806809
- Firm city
- Charlottetown
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28